NCT06175962

Brief Summary

Menopause; cessation of menstruation due to cessation of follicular activity is the transition from the reproductive period to non-reproductive life. Considering that the average life expectancy is increasing, women spend most of their lives in the menopausal period. Women who have a positive attitude towards menopause have a positive body image, experience less depressive experiences, and the severity of menopause symptoms decreases. It has also been assumed that spiritual well-being is effective in reducing the severity of menopause symptoms and anxiety, supporting positive body image, and coping with losses. Baduanjin exercise is a type of body mind exercise. It increases the production of life energy and distributes it to different aspects of the body. It is thought that the baduanjin body-mind exercise to be applied to perimenopausal women will have positive effects on the spiritual well-being of menopausal women and their attitudes towards menopause. Thus, it is expected that women's transition and adaptation to the menopause process will be easier.

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Dec 2023

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
enrolling by invitation

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 10, 2023

Completed
9 days until next milestone

First Posted

Study publicly available on registry

December 19, 2023

Completed
1 day until next milestone

Study Start

First participant enrolled

December 20, 2023

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 15, 2024

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 30, 2024

Completed
Last Updated

February 20, 2024

Status Verified

February 1, 2024

Enrollment Period

2 months

First QC Date

December 10, 2023

Last Update Submit

February 19, 2024

Conditions

Keywords

PerimenopauseBaduanjinMenopause attitude

Outcome Measures

Primary Outcomes (1)

  • Attitude Scale towards Menopause (MITÖ)

    It was developed by Uçanok (1994) to measure the attitudes of women in different age groups towards menopause and its aftermath. There are a total of 20 statements in the scale, 2 positive and 18 negative. The scale is a four-point Likert type. For negative expressions, scoring is done in the opposite direction. The lowest score that can be obtained from the scale is 0 and the highest score is 80. It is accepted that the higher the scores above the average score of 40, the more positive the attitude.

    14 WEEKS

Secondary Outcomes (1)

  • Spirituality Index of Well-Being Scale

    14 WEEKS

Study Arms (2)

Experimental Group

EXPERIMENTAL

At the beginning of the research, the Introductory Information Form, the Attitudes Towards Menopause Scale (MITÖ), and the Spirituality Index Well-Being Scale will be applied to the experimental group. Later, menopause health education will be given to women within the scope of the menopause adaptation program prepared based on Meleis's transition theory. Then, the women will be taught the baduanjin exercise for 4 weeks by the researcher who has a Qigong practitioner certificate. All training will be held online. After making sure that the women have learned the baduanjin exercise, they will be asked to do the baduanjin exercises at home 3 times a week for 8 weeks. During this process, counseling services will be provided and women will be followed. The study will be completed in 14 weeks, after which posttest data will be collected.

Behavioral: TRAINING AND EXERCISE

Control Group

NO INTERVENTION

At the beginning of the research, the Introductory Information Form, Attitudes Towards Menopause Scale (MITÖ), and Spirituality Index Scale will be applied to the control group. No intervention will be made to the control group.

Interventions

Menopause health training will take place in 2 sessions each week and will be completed in 4 sessions. Each session duration is 45 minutes. Baduanjin exercise training will take place in 2 sessions per week, each session lasting 30 minutes. It will be completed in 8 sessions in total. Relaxing music will be played during the Baduanjin exercise and relaxation will be encouraged. During the Baduanjin exercise, proper posture, conscious breathing and focus of the mind will be prioritized. While the movements are being implemented, their symbolic meanings will be explained to the participants. Women will be asked to perform baduanji 3 times a week for 8 weeks. During this process, reminder messages will be sent to women via WhatsApp.

Experimental Group

Eligibility Criteria

Age45 Years - 55 Years
Sexfemale(Gender-based eligibility)
Gender Eligibility DetailsWomen in the perimenopausal period according to the Staging of Reproductive Aging in Women (STRAW) criteria
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Being in the perimenopausal period
  • Being between the ages of 40-55
  • Having entered menopause naturally
  • Volunteering to participate in research

You may not qualify if:

  • Having a physical problem that prevents exercise
  • Being on hormone therapy
  • Not having a menstrual period for more than 8 months
  • Not using a smartphone

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Aynur ATAMAN KUFACI

Sinop, 57000, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Motor ActivityBehavior

Interventions

Exercise

Intervention Hierarchy (Ancestors)

Motor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Officials

  • Aynur ATAMAN KUFACI

    Sinop University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Masking Details
Double (Participant, Investigator)
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Model Details: Parallel Assignment
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 10, 2023

First Posted

December 19, 2023

Study Start

December 20, 2023

Primary Completion

February 15, 2024

Study Completion

August 30, 2024

Last Updated

February 20, 2024

Record last verified: 2024-02

Data Sharing

IPD Sharing
Will not share

Locations